Automation Engineer - QBMS

Automation Engineer – QBMS | Toulouse, France

Just-Evotec Biologics is seeking a motivated Automation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.  The Automation Engineer will be part of the JPOD2 Automation team in the MTS/MSAT department. The incumbent will serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site Building Management Systems for a clinical and commercial manufacturing site at the Toulouse J.POD manufacturing facility. The successful candidate will have demonstrated proficiency in Automation and Instrumentation Design and Validation, Systems integration using industry standard protocols (BACnet, Profinet, OPC, Hart) with related business and automation systems, and an understanding of ISA-95 Operational Technology architecture. Experience working in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is required.

Responsibilities:

• Serve as the site-level lead or support for the configuration, implementation, validation, and lifecycle management of the site Building Management Systems.
• Support the definition of equipment and User Requirements
• Support the Design and Development of the Building Automation Solutions
• Evaluate new equipment and new technologies prior to implementation
• Maintain compliance with company standards.
• Define maintenance requirements and spare parts management
• Participate in impact assessment for equipment/system failures
• Develop and implement lifecycle documentation for the BMS system including user requirements, design and functional specifications, SOPs, training documents, etc.
• Collaborate with the validation team for the initial and ongoing qualification of the QBMS system and related instrumentation. Ensure full regulatory compliance including requirements for GMPs and data integrity.
• Provide on-demand technical support including troubleshooting and issue resolution related to Automation system infrastructure, configuration and interfaces to support operational requirements.
• Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
• Provide project oversight on BMS implementation projects contracted to vendors or 3rd party suppliers/integrators.

Position Requirements:

• Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
• Experience with PCVue, Siemens PLC, TIA Portal platforms
• 5+ years relevant experience in pharmaceutical, biotech, or life sciences with 5+ years of experience with current Good Manufacturing Practice (cGMP) regulations
• Strong control system automation background including design, installation, programming and validation of automated processes
• Working knowledge of cGMP manufacturing and regulatory regulations and requirements (FDA CFR 21 Part 11 and EMA Annex 11) for biologics/pharmaceuticals
• Leverage experience of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
• Established record of successful project completions employing proven engineering skills
• Demonstrated skills coding in Siemens Platforms (TIA Portal)
• Demonstrated skills developing HMI and SCADA (PCVue, WinCC)
• Demonstrated skills designing and integrating instrumentation in BMS
• Candidate must possess strong focus on quality and attention to detail
• Good interpersonal, team, and communication skills are a must
• Excellent oral and written communication skills in both English and French

Additional Preferred Qualifications:

• Experience in computer software validation in both writing test scripts and executing test protocols is strongly preferred
• Experience using GAMP5 risk-based approach when implementing changes to validated software systems
• Experience in supporting audits and inspections by health authorities and other external auditors
• Experience with DeltaV

Proficiency developing and executing CSV plans and protocols

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.